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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

Virus Counter Platform with Model Name VC3100

FDA Recall
Open, Classified ·Sartorius Corporation·Product code REQ·March 11, 2022

TASE 500 Imaging systems

FDA Recall
Open, Classified ·COLLINS AEROSPACE·Product code RET·January 29, 2019

Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.

FDA Recall
Terminated ·Nikon Metrology·Product code RCE·December 23, 2019

ClubMax Laser Projection Series

FDA Recall
Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.

FDA Recall
Open, Classified ·IN MY BATHROOM LLC·Product code RHP·January 27, 2022

Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD

FDA Recall
Open, Classified ·YAMAHA MOTOR CORPORATION·Product code RGA·April 17, 2024

Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon Catalog # 4544

FDA Recall
Terminated ·Boston Scientific Corporation·January 29, 2003

Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005

FDA Recall
Terminated ·Ascension Orthopedics, Inc·Product code ---·October 31, 2002

Bard Orbiter PV Steerable Catheter Item #: 320100 (Marketed in Europe Only)

FDA Recall
Terminated ·C. R.Bard, Inc./Electrophysiology Division·January 8, 2003

Intellivue Information Center Model: M3150B#C01

FDA Recall
Terminated ·Philips Medical Systems, Inc. Cardiac & Monitoring Systems·January 2, 2003